Multi-Center Research Project History

Title of Study:  “A Prospective Randomized Trial Investigating the Effect of a Novel Reamer-Irrigator-Aspirator on the Incidence of Fat Embolism and Respiratory Function During  Intramedullary Nailing of Femoral Shaft Fractures”

Brief Description: The RIA study is a multi-centre trial with a principle site (St. Michael's Hospital) and an additional five participating co-invesitgative sites.  These centers include:
* St. Michael's Hospital (Toronto), Lead Site
Investigators: Dr. E. Schemitsch, Dr. M. McKee
* McMaster University (Hamilton Health Sciences Centre)
Investigators: Dr. M. Bhandari, Dr. B. Petrisor
* Montreal General hospital
Investigators: Dr. E. Harvey, Dr. R. Reindl, Dr. G. Berry
* Queen Elizabeth II Health Sciences Centre (Halifax)
Investigators: Dr. R. Leighton
* Germany
Investigators: Dr. HC Pape
* Sunnybrook Health Sciences Centre (Toronto)
Investigators: Dr. H. Kreder, Dr. D. Stephen

Unfortunately, due to the complexity of maintaining a RIA study team to capture all the required data, previous centres (i.e. Ottawa and Vancouver) had to withdraw due to their inability to maintain a RIA study team.  The study is demanding in that constant communication and coordination is needed beetween the study coordinator, anaesthesia, the surgeon, and the transesophageal echocardiogram technician.

All the participating sites have up-to-date Research Ethics Board (REB/IRB) approval and are actively recruiting participants. The research team anticipates that each site will enroll approximately five to ten study participants in order to reach the total goal of 46 participants enrolled with one year follow-up. 
Presently, a total of 13 patients enrolled with complete data to date.


 

Title of Study:  Fluid Lavage of Open Wounds (FLOW): A Multi-center, Blinded, Factorial Trial Comparing Alternative Irrigating Solutions and Pressures in Patients with Open Fractures

Brief Description: This study is a multinational, multi-center factorial design randomized trial to evaluate the effect of soap versus normal saline and different irrigating pressures (high pressure, low pressure, and gravity flow pressure) in the management of open fracture wounds on the primary outcome--rates of reoperation to treat infection, or managing wound or fracture healing problems. We will also evaluate functional outcome and health-related quality of life as part of this trial. We recently completed the FLOW pilot study, which was OTA funded, and are now moving forward with our definitive trial of 2,280 patients with open fracture wounds. 

Number of sites: 45 (target)

Recruiting More Investigators: Yes

Primary Contact: Mohit Bhandari
Phone: 905-527-4322 ext 44490
Fax: 905-523-8781
E-mail: bhandam@mcmaster.ca

 ♦ OTA Funded (Pilot Study)


Title of Study: Prospective Randomized Clinical Study to Evaluate the Effects of Less Invasive Stabilization System (LISS) Plating Technique in Distal Femoral Fractures.

Brief Description: This study compares the new Less Invasive Stabilization System (LISS) to the standard plates used for fracture fixation in the distal femur. The standard plates are the dynamic condylar screw in Type A, B, and C fractures, where possible and the condylar buttress plate in Type C fractures with coronal splits when a fixed angled device is not possible. The purpose of the study is to determine whether the rate of fracture healing and fracture union with the LISS device will be as good as or better than the usual fracture fixation systems.

Number of sites: 8
Currently recruiting new investigators/sites? No

Primary Contact: Ross Leighton (PI - lead site)
Phone: (902) 473-4035
Fax: (902) 473-4490
E-mail: r.k.leighton@ns.sympatico.ca


Title of Study: A Prospective Randomized Multicentre Clinical Trail Comparing Open Reduction Internal Fixation with Primary Subtalar Fusion in Patients with Severely Comminuted (Sanders IV) Displaced, Intra-articular Fractures of the Calcaneus

Brief Description: Displaced, Sanders IV fractures with at least three fracture lines across the posterior subtalar facet usually result from high energy injury and have done poorly with both non operative and operative management. Nearly 50% of these patients go on to have fusion of the subtalar joint due to severe subtalar pain from the development of osteoarthritis. Eligible patients with Sander IV calcaneal fractures will be randomized to undergo ORIF or primary fusion as their first option. All patients will be followed for two years with assessments performed at five points.

Number of sites: 3
Currently recruiting new investigators/sites? Yes
Lead Site: Foothills Medial Centre, Calgary, Alberta
Status: Active and Currently Enrolling Patients

Primary Contact: Ross Leighton (local site PI)
Phone: (902) 473-4035
Fax: (902) 473-4490
E-mail: r.k.leighton@ns.sympatico.ca


Title of Study: Multicenter Prospective Randomized Transfusion Therapy Trial For Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair

Brief Description: The overall goal is to determine whether a more aggressive transfusion strategy in patients with cardiovascular disease undergoing surgery for repair of hip fracture is associated with improved functional recovery and decreased risk of adverse postoperative outcomes. Patients will be randomized into one of tow transfusion groups in a three day post op window: patients assigned to the 10g/dL arm will receive enough blood to maintain their blood count at or above 10g/dL, patients assigned to the symptomatic arm will receive a blood transfusion only if their blood count falls below 8g/dL. Follow-up @ 30 and 60 days with in-hospital Troponin levels (not for treatment) to be batched to the core lab and standard in-hospital ECG and Hbb levels to be recorded.

Number of sites: 25
Lead Site: UMDNJ - Robert Wood Johnson Medical School, New Brunswick, NJ
Currently recruiting new investigators/sites? N/A
Status: Active and Currently Enrolling Patients

Primary Contact: Ross Leighton (local site PI)
Phone: (902) 473-4035
Fax: (902) 473-4490
E-mail: r.k.leighton@ns.sympatico.ca


Title of Study: The Effect of Teriparatide on Distal Radius Fractures Healing: A randomized, double-blinded multicenter trail.

Brief Description: Forteo® (Teriparatide), the human parathyroid hormone fragment PTH (1-34) is an anabolic agent that induces bone formation by activating osteoblasts and promoting differentiation of precursors into osteoblasts. It is the first bone forming agent that has been approved for the treatment of postmenopausal women with osteoporosis by increasing bone mineral density and decreasing fracture risk. Animal studies suggest that teriparatide may increase osseous integration and enhance mineralization of newly formed bone matrix as well as accelerate fracture healing by increasing callous formation and mechanical strength. This six moth study is a Phase 2 prospective, randomized, parallel, double-blind, placebo-controlled, multi-centered, multi-national, study. It will evaluate the effect of teriparatide on fracture healing in postmenopausal women who have sustained a unilateral, dorsally angulated, distal radius fracture. "The primary objective will be to determine whether teriparatide, at a dose approved for treatment of osteoporosis, enhances the rate of distal radius fracture healing as evidenced by both radiographic changes (plain film and CT) and functional outcome scores. Given the known anabolic properties of low-dose intermittent parathyroid hormone in human subjects and the intriguing data on fracture healing at higher doses of parathyroid hormone in animals, we hypothesize that patients receiving teriparatide after distal radius fractures will show significantly improved rates of fracture healing both radiographically and functionally. We also expect to see significantly fewer orthopedic complications such as delayed union, or nonunion in those receiving teriparatide. Teriparatide induced fracture healing has the potential to reduce the time for injured patients to return to normal functioning and reduce the overall costs of fracture care.

Number of sites: 11
Currently recruiting new investigators/sites? No
Status: Active and Currently Enrolling Patients

Primary Contact: Brian Su, MD
Phone: (212) 305-3912
Fax: (212) 342-1749
E-mail: bws7@columbia.edu


Title of Study: The Effects of Early Active Motion Rehabilitation after Teno Fix Tendon Repair in Zone II Flexor Tendon Lacerations of the Hand

Brief Description: Flexor tendon injuries of the hand represent a challenge for even the most experienced hand surgeon. The tendons of the hand are divided into anatomically and biomechanically complex area. The standard of care is to allow tendon healing prior to passive motion rehabilitation with mobilization being the key to preventing adhesions and achieving maximum range of motion post-operatively. However, if mobilization is performed too early in the presence of a weak tendon repair, there is risk of rupture. The Teno Fix tendon repair system, designed specifically to address these difficulties, offers a stronger and more stable tendon repair construct. This allows for early mobilization and we propose this study to evaluate the advantages of an early active motion rehabilitation program after tendon repair with the Teno Fix system. Our hypothesis is that early active motion rehabilitation will lead to a better range of motion of the affected finger while maintaining a low rupture rate. Patients with Zone II flexor tendon lacerations repaired with the Teno Fix device will undergo an early active motion protocol developed at the New York Orthopaedic Hospital, as tolerated by patients, starting post-op day 3. Each patient will be followed and our analysis will focus on range of motion, strength, pain, swelling, and functional outcome assessment with a limb specific questionnaire called the DASH (Disabilities of the Arm, Shoulder, and Hand).

Number of sites: Undetermined
Currently recruiting new investigators/sites? Yes

Primary Contact: Brian Su, MD
Phone: (212) 305-3912
Fax: (212) 342-1749
E-mail: bws7@columbia.edu


Title of Study: A Multi-center, Prospective, Randomized Trial of Non-Operative versus Operative Treatment for High-Energy Midshaft Clavicle Fractures

Brief Description: To examine the nonunion rates and functional outcomes (DASH, SF-36) complications for closed tx, plating and clavicle pinning.

Number of sites: Currently 11 IRB approved sites actively collecting patients
Currently recruiting new investigators/sites? Yes
Status: Active and Currently Enrolling Patients

Primary Contact: Stephanie Tanner (for Kyle Jeray, MD)
Phone: (864) 455-7878
Fax: (864) 455-7082
E-mail: stanner@ghs.org
 
 ♦ OTA Funded


Title of Study: Displaced Intra-articular Sanders IV Calcaneal Fractures - ORIF versus Fusion - A Prospective Randomized Trial

Brief Description: This is a prospective randomized trial that deals with the worst displaced intra-articular calcaneal fractures. Patients will be randomized into operative versus fusion groups with 2-year follow-up. They will initially be assessed with CT scans. They will have intra-operative reconstruction of the hind foot, or intra-operative reconstruction of the hind foot with denuding of the cartilage services and fusion. They will have 8 weeks of non-weight bearing with regular follow up with standardized calcaneal surgeon manning the site.

Number of sites: Multiple sites across Canada with experienced calcaneal surgeons. 
Currently recruiting new investigators/sites? No
** As of June 2009, three quarters finished with patient accrual.  Two year follow-up is needed
for each patients.

Primary Contact: Richard Buckley, MD
Phone: (403) 944-8371
Fax: (403) 270-8004
E-mail: buckclin@ucalgary.ca

 ♦ OTA Funded